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Studying effectiveness of Short Term oral Magnesium supplement Prophylaxis In Menstrually Related Migraine (MRM) in women in reproductive ages : A Randomized Controlled Trial

Protocol summary

Study aim
Evaluate effect of short term oral magnesium prophylaxis on prevention, frequency, intensity, prolongation, amount of analgesic drugs and resulting palliation In Menstrually Related Migraine (MRM) headache attacks.
Design
In this blinded, randomized, concealed clinical trial with a parallel group design patients examine for 3 continuous months in magnesium users and placebo users subgroups.
Settings and conduct
Each qualified patient fill out questionnaire about her MRM headache attacks features in 1 month without any magnesium or placebo usage initially, then a third person divides participants into magnesium and placebo groups randomly (random allocation rule) and also he is the only person who has access to patient's personal information, then he gives out tablets according to each person's group and after passing 3 months he collect questionnaires and records data and reports them anonymously to researcher and analyzer.
Participants/Inclusion and exclusion criteria
Women of reproductive age who have regular menses and affected by Menstrually Migraine, meet the last International Classification of Headache Disorders's (ICHD) criteria for MRM and doesn't fill the exclusion criteria that was named.
Intervention groups
Half of the qualified patients use 375 milligrams oral magnesium (magnesium oxide tablets) and the other half also use placebo tablets which are exactly the same size, smell and color, for 3 continuous Menstrual cycles from fifteenth day of each cycle to the third day of next one.
Main outcome variables
group (magnesium and placebo), age, menstrual cycle length, headache frequency, intensity, prolongation, amount of analgesic drugs and resulting palliation, side effects

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190415043284N1
Registration date: 2019-08-15, 1398/05/24
Registration timing: retrospective

Last update: 2019-08-15, 1398/05/24
Update count: 0
Registration date
2019-08-15, 1398/05/24
Registrant information
Name
pegah Yabande jahrom
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8255
Email address
yabande.p@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-03-16, 1397/12/25
Actual recruitment start date
2019-01-21, 1397/11/01
Actual recruitment end date
2019-04-19, 1398/01/30
Trial completion date
2019-07-21, 1398/04/30
Scientific title
Studying effectiveness of Short Term oral Magnesium supplement Prophylaxis In Menstrually Related Migraine (MRM) in women in reproductive ages : A Randomized Controlled Trial
Public title
Short Term Magnesium Preventation In Menstrually Related Migraine (MRM)
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
patients affected by menstrually related migraine according to 3rd edition of The International Classification of Headache Disorders regular mense
Exclusion criteria:
chronic diarrhea renal failure nephrolithiasis myasthenia gravis patients anti hypertensive drug usage particularly calcium channel blocker users diabetic patients who has insulin resistance state pregnancy or planned pregnancy; ; menstrual migraine [14] breast feeding women non migraine headache psychiatric illness according to DSM5 criteria chronic systemic illness dependence or abuse of drugs intake of antidepressants, neuroleptics, minor or major tranquillizers, drugs used for the treatment of affective disorders (e.g. lithium, carbamazepine), antiepileptics bradrychardia anti coagulant and antiplatelet usage pure menstrually migraine
Age
From 20 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Actual sample size reached: 42
Randomization (investigator's opinion)
Randomized
Randomization description
Participants assign to comparison groups (allocation sequence) with random allocation rule (a form of restricted randomisation procedures- after sample taking finished, we put magnesium and placebo papers, half and half number in a sortition container and bring them out randomly to make an allocation sequence.) and this allocation conceals by central randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants are unaware of who is receiving the real treatment and by means of a third party who collected data and bring them anonymous to assessor and and analyser blinding done.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
No. 3,Mahsa building, Alley 13, Khadem Sadeq Ave., Amir Kabir Blv., shiraz
City
Ahvaz
Province
Khouzestan
Postal code
۷۱۷۸۷۴۴۳۵۹
Approval date
2018-05-05, 1397/02/15
Ethics committee reference number
IR.AJUMS.REC.1397.083

Health conditions studied

1

Description of health condition studied
Menstrually Related Migraine (MRM)
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
headache attacks of menstrually related migraine
Timepoint
4 questionnaires are filled: the first one at the sampling time and 3 others during 3 continuous menstrual cycles which the participant take pills.
Method of measurement
questionnaire

Secondary outcomes

1

Description
headache frequency, intensity, prolongation, amount of analgesic drugs and resulting palliation
Timepoint
4 questionnaires are filled: the first one at the sampling time and 3 others during 3 continuous menstrual cycles which the participant take pills.
Method of measurement
Each questionnaire contains a calendar with blanks to record: the exact date of menstruation starting date, headache days, headache intensity ( 1 to 10 scale), each headache attack prolongation (hours), number of analgesic pills to pain relief and resulting palliation (describes with excellent, good, intermediate and poor response)

Intervention groups

1

Description
Intervention group: each patient during 3 continuous menstrual cycles, taking one and half (375 milligrams) of 250 miligrames magnesium oxide pills from Jalinous Pharmaceutical company daily and records headaches from 2 days before menstruation up to third day of mens. Control group: each patient during 3 continuous menstrual cycles, taking one and half of placebo pills daily and records headaches from 2 days before menstruation up to third day of mens.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Ehsan Mohammadiani Nejad
Street address
Neurology ward, Golestan hospital, Farvardin Aven., Golestan Blv..
City
Ahvaz
Province
Khouzestan
Postal code
33118-61357
Phone
+98 61 3374 3001
Email
p.yabande@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Ahvaz jundishapur university of medical sciences, Golestan Blv.
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3373 8383
Email
p.yabande@gmaill.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
30
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ehsan Mohammadiani Nejad
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Neurology ward, Golestan hospital, Farvardin Aven., Golestan Blv..
City
Ahvaz
Province
Khouzestan
Postal code
33118-61357
Phone
+98 61 3374 3001
Email
p.yabande@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ehsan Mohammadiani Nejad
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Neurology ward, Golestan hospital, Farvardin Aven., Golestan Blv..
City
Ahvaz
Province
Khouzestan
Postal code
33118-61357
Phone
+98 61 3374 3001
Email
p.yabande@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ehsan Mohammadiani Nejad
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Neurology ward, Golestan hospital, Farvardin Aven., Golestan Blv..
City
Ahvaz
Province
Khouzestan
Postal code
33118-61357
Phone
+98 61 3374 3001
Email
p.yabande@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data about magnesium prophylaxis effects on menstrually related migraine headaches and its Side effects will share.
When the data will become available and for how long
at least 6 months after the date that results have been published.
To whom data/document is available
researchers who work for universities
Under which criteria data/document could be used
To investigate weak points of this study to obtain and start a new and more useful work
From where data/document is obtainable
Dr Ehsan Mohammadiani Nejad, neurology ward, Ahvaz Jundishapur university of medical sciences
What processes are involved for a request to access data/document
Deliver a request containing exact description of reasons for this request and make a list of the exact data which is needed, to the neurology group. this request will be checked as soon as possible and will be answered.
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